This rulemaking is to implement 2019 Senate Bill 1020, creating s. 581.217, F.S., which requires the Department to administer the state hemp program. This proposed rule will regulate “hemp extract” as a food.

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-4.034Hemp Extract

PURPOSE AND EFFECT: This rulemaking is to implement 2019 Senate Bill 1020, creating s. 581.217, F.S., which requires the Department to administer the state hemp program. This proposed rule will regulate “hemp extract” as a food.

SUMMARY: Section 581.217, F.S., defines Hemp Extract as a substance or compound intended for ingestion, rendering Hemp Extract a Food as defined in ch. 500, F.S. Therefore, establishments manufacturing, processing, packing, holding, preparing, or selling food consisting of or containing Hemp Extract at wholesale or retail must possess a food permit pursuant to ch. 500, F.S. This rulemaking will adopt a process by which Hemp Food Establishments may be permitted, applicable permitting requirements, labeling requirements, and guidelines for administering penalties for violations of the proposed rule and ch. 500, F.S.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: There are no adverse regulatory impacts associated with industry compliance with this proposed rule. Food Establishments voluntarily electing to manufacture, process, pack, hold, prepare, or sell food consisting of or containing Hemp Extract will be required to have a food permit pursuant to ch. 500, F.S. The Department recognizes that costs and expenses related to implementation includes fees pursuant to ch. 500, F.S., waste disposal pursuant to s. 581.217(12)(b), F.S., laboratory testing pursuant to s. 581.217(7)(a), F.S., and labeling and packaging pursuant to s. 581.217(7)(b), F.S., pose costs to permittees. However, those costs are prescribed by statute and do not originate from rules of the Department. Therefore, these costs are not regulatory costs of the proposed rule pursuant to s. 120.54(3)(b), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 500.09, 500.12, 570.07(23), FS.

LAW IMPLEMENTED: 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217, FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: October 18, 2019, 9:00 a.m.

October 21, 2019, 9:00 a.m.

PLACE: October 18 - Cabinet Meeting Room, The Capitol, Lower Level, 400 South Monroe Street, Tallahassee, Florida 32399

October 21 - Florida State Fairgrounds, 4800 US-301, Tampa, FL 33610

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Holly Bell via email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-4.034 Hemp Extract in Food

(1) Products. Hemp or Hemp Extract intended to be ingested is a Food as defined in s. 500.03, F.S., and are subject to the requirements of ch. 500, F.S., and Rules 5K-4.002; 5K-4.004; 5K-4.020; 5K-4.021, and 5K-4.035, F.A.C., in addition to the requirements of this rule.

(2) Definitions. The definitions provided in ss. 500.03, 581.217, F.S., and the following shall apply to this rule:

(a) “Approved Source” for the purposes of this rule means a food establishment manufacturing, processing, packing, holding, or preparing food or selling food at wholesale or retail that meets local, state, or federal food safety standards from the jurisdiction of origin.

(b) “Batch Number” or “Lot Number” means the Hemp Extract produced during a period of time under similar conditions and identified by a specific code that allows traceability.

(c) “Expiration Date” means the month and year as determined by the manufacturer, packer, or distributor on the basis of tests or other information showing that the product, until that date, under the conditions of handling, storage, preparation, and use per label directions, will when consumed, contain not less than the quantity of each ingredient as set forth on its label. 

(d) “Hemp” is defined in s. 581.217(3)(d), F.S.

(e) “Hemp Extract” is defined in s. 581.217(3)(e), F.S. Hemp Extract does not include any material, compound, mixture or preparation that contains any quantity of Synthetic Cannabinoids as defined in s. 893.03(1)(c)190., F.S.

(f) “Hemp Food Establishment” means an establishment as defined in s. 500.03(1)(p), F.S., manufacturing, processing, packing, holding, preparing, or selling Food consisting of or containing Hemp Extract at wholesale or retail.

(g) “Ingestion” means the process of taking Food into the body through the mouth and into the gastrointestinal tract through eating or drinking.

(h) “Total delta-9 tetrahydrocannabinol concentration” means [delta-9 tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid]).

(3) Food Permit Fees. Hemp Food Establishments shall obtain a food permit as required in Rule 5K-4.020, F.A.C., and shall pay an annual fee of $650.

(4) Requirements.

(a) Food consisting of or containing Hemp or Hemp Extract must be obtained from an Approved Source. The Hemp Food Establishment shall provide to the department, upon request, a valid food license/permit and the most recent food safety inspection report from the Approved Source.

(b) Food consisting of or containing Hemp Extract may not be manufactured, processed, packed, held, prepared, or sold under the Cottage Food Operations Law in s. 500.80, F.S.

(c) If a Food is considered a Potentially Hazardous Food (PHF) or a Food requiring Time and Temperature Control for Safety (TCS Food) as defined in 5K-4.0010, F.A.C., it must be stored in accordance with Rule 5K-4.002, F.A.C. All Food products consisting of or containing Hemp Extract must be packaged in containers minimizing the exposure to light to prevent degradation of the Cannabinoids.

(d) Food consisting of or containing Hemp Extract shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3% on a dry weight basis.

(5) Contaminants. In addition to the requirements listed in ch. 500, F.S., and Rule 5K-4.002, F.A.C., Food consisting of or containing Hemp Extract shall be considered adulterated pursuant to s. 500.10(1)(a), F.S., if contaminants are detected at levels greater than those listed in this rule.

(a) Pesticide Limits. The following list of contaminants does not constitute authorization to use or apply any of the following during Hemp cultivation or processing.

1. Abamectin, 300 parts per billion.

2. Acephate, 3,000 parts per billion.

3.Acequinocyl, 2,000 parts per billion.

4. Acetamiprid, 3,000 parts per billion.

5. Aldicarb, 100 parts per billion.

6. Azoxystrobin, 3,000 parts per billion.

7. Bifenazate, 3,000 parts per billion.

8. Bifenthrin, 500 parts per billion.

9. Boscalid, 3,000 parts per billion.

10. Captan, 3,000 parts per billion.

11. Carbaryl, 500 parts per billion.

12. Carbofuran, 100 parts per billion.

13. Chlorantraniliprole, 3,000 parts per billion.

14. Chlordane, 100 parts per billion.

15. Chlorfenapyr, 100 parts per billion.

16. Chlormequat chloride, 3,000 parts per billion

17. Chlorpyrifos, 100 parts per billion.

18. Clofentezine, 500 parts per billion.

19. Coumaphos, 100 parts per billion.

20. Cyfluthrin, 1,000 parts per billion.

21. Cypermethrin, 1,000 parts per billion.

22. Daminozide, 100 parts per billion.

23. DDVP (Dichlorvos), 100 parts per billion.

24. Diazinon, 200 parts per billion.

25. Dimethoate, 100 parts per billion.

26. Dimethomorph, 3,000 parts per billion.

27. Ethoprop(hos), 100 parts per billion.

28. Etofenprox, 100 parts per billion.

29. Etoxazole, 1,500 parts per billion.

30. Fenhexamid, 3,000 parts per billion.

31. Fenoxycarb, 100 parts per billion.

32. Fenpyroximate, 2,000 parts per billion.

33. Fipronil, 100 parts per billion.

34. Flonicamid, 2,000 parts per billion.

35. Fludioxonil, 3,000 parts per billion.

36. Hexythiazox, 2,000 parts per billion.

37. Imazalil, 100 parts per billion.

38. Imidacloprid, 3,000 parts per billion.

39. Kresoxim-methyl, 1,000 parts per billion.

40. Malathion, 2,000 parts per billion.

41. Metalaxyl, 3,000 parts per billion.

42. Methiocarb, 100 parts per billion.

43. Methomyl, 100 parts per billion.

44. Methyl parathion, 100 parts per billion.

45. Mevinphos, 100 parts per billion.

46. Myclobutanil, 3,000 parts per billion.

47. Naled, 500 parts per billion.

48. Oxamyl, 500 parts per billion.

49. Paclobutrazol, 100 parts per billion.

50. Pentachloronitrobenzene, 200 parts per billion.

51. Permethrin, 1,000 parts per billion.

52. Phosmet, 200 parts per billion.

53. Piperonyl butoxide, 3,000 parts per billion.

54. Prallethrin, 400 parts per billion.

55. Propiconazole, 1,000 parts per billion.

56. Propoxur, 100 parts per billion.

57. Pyrethrins, 1,000 parts per billion.

58. Pyridaben, 3,000 parts per billion.

59. Spinetoram, 3,000 parts per billion.

60. Spinosad A & D, 3,000 parts per billion.

61. Spiromesifen, 3,000 parts per billion.

62. Spirotetramat, 3,000 parts per billion.

63. Spiroxamine, 100 parts per billion.

64. Tebuconazole, 1,000 parts per billion.

65. Thiacloprid, 100 parts per billion.

66. Thiamethoxam, 1,000 parts per billion.

67. Trifloxystrobin, 3,000 parts per billion.

(b) Residual Solvent Limits.

1. 1,2-Dichloroethene, 5 parts per million

2. 1,1-Dichloroethene, 8 parts per million

3. Acetone, 5,000 parts per million

4. Acetonitrile, 410 parts per million

5. Benzene, 2 parts per million

6. Butane, 2,000 parts per million

7. Chloroform, 60 parts per million

8. Ethanol, 5,000 parts per million

9. Ethyl Acetate, 5,000 parts per million

10. Ethyl Ether, 5,000 parts per million

11. Ethylene Oxide, 5 parts per million

12. Heptane, 5,000 parts per million

13. Hexane, 290 parts per million

14. Isopropyl Alcohol, 500 parts per million

15. Methanol, 3,000 parts per million

16. Methylene Chloride, 600 parts per million

17. Pentane, 5,000 parts per million

18. Propane, 2,100 parts per million

19. Toluene, 890 parts per million

20. Trichloroethylene (1,1,2-Trichloroethene), 80 parts per million

21. Xylenes, Total (ortho-, meta-, para-), 2170 parts per million

(c) Metals Limits.

1. Cadmium, 0.5 micrograms/gram.

2. Lead, 0.5 micrograms/gram.

3. Arsenic, 1.5 micrograms/gram.

4. Mercury, 3.0 micrograms/gram.

(d) Biological Limits.

1. Shiga toxin-producing Escherichia coli (STEC E. coli) and other pathogenic E. coli, none present.

2. Listeria monocytogenes, none present.

3. Salmonella, none present.

(e) Mycotoxin Limits.

1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion.

2. Ochratoxin, 20 parts per billion.

(f) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3% on a dry weight basis.

(g) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, or pesticide not enumerated in this rule or by Florida law, then the Food shall be considered adulterated.

(6) Labeling.

(a) Food consisting of or containing Hemp Extract must be labeled as required by ch. 500, F.S., s. 581.217(7), F.S., and 21 CFR Part 101, as incorporated by reference in Section 5K-4.002(4), F.A.C., and must declare the number of milligrams of Hemp Extract.

(b) If specific cannabinoids are marketed, the number of milligrams of each cannabinoid per serving must be declared on the label. The serving size shall be displayed on the nutrition facts label of the product.   

(c) The label and advertisement shall not contain claims indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease, rendering it a drug as defined in 21 U.S.C. 321(g)(1).  Pursuant to s. 500.03(1)(n)4., F.S., such articles are not considered Food and shall be considered misbranded as Food.

(7) Disposal.

(a) Laboratory samples found to contain more than a Total delta-9 tetrahydrocannabinol concentration of 0.3% on a dry weight basis shall be disposed of in accordance with 21 CFR 1317. 21 CFR 1317 (Revised January 1, 2019) is hereby incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

(b) Food containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis shall be detained pursuant to s. 500.172, F.S. Food containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis which has been detained pursuant to s. 500.172, F.S. shall not be further subdivided or renumbered such that the integrity of the lot is not maintained. The establishment shall not dispose of the Food in any manner until written permission is given by the department or a court of competent jurisdiction.

(c) Upon receipt of written permission by the department or a court of competent jurisdiction, the Food shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 10/19, incorporated in paragraph 5B-57.014(6)(b), F.A.C., or in a manner approved by a court of competent jurisdiction. Upon destruction of the product, the Hemp Food Establishment shall notify the department via Notice of Disposal FDACS-14419, 10/19, incorporated herein by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

(8)  Penalties. Violations of this rule will be evaluated and penalties imposed in accordance with Rule 5K-4.035, F.A.C.

Rulemaking Authority 500.09, 500.12, 570.07(23), FS. Law Implemented 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217, FS. History-New                     . 

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dr. Matthew Curran, Director Division of Food Safety

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Commissioner of Agriculture Nicole Fried

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 08, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 6, 2019